Oxytocin augmentation vs conservative management for primary dysfunctional labour in nulliparous women: a randomised, controlled trial.

ISRCTN	ISRCTN78205641
DOI	https://doi.org/10.1186/ISRCTN78205641
Protocol serial number	MCH 02-17
Sponsor	Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)
Funder	NHS Mother and Child Health National Research and Development Programme (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Kim Hinshaw
Scientific

Obstetrics and Gynaecology
City Hospitals Sunderland NHS Trust
Kayll Road
Sunderland
SR4 7TP
United Kingdom

Phone	+44 (0)191 5656256

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	The aim of the study is to find out whether oxytocin reduces Caesarean Section Rates to assess its effects on other labour and neonatal outcomes and in particular to assess its effects on maternal perception of pain etc and satisfaction with labour.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Pregnancy and childbirth: Childbirth
Intervention	Not provided at time of registration
Intervention type	Other
Primary outcome measure(s)	A scientific evaluation of a widely introduced but as yet unproven labour intervention. It will look at the health gain in terms of any subsequent psychological dysfunction. The effects of the different interventions on the Caesarean Section Rates is another primary outcome measure. Any reduction in the Caesarean Section Rate is likely to have economic benefit to the NHS in terms of cost reduction.
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/02/2002

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	412
Key inclusion criteria	Women in spontaneous labour in their first pregnancy at term (37-42 weeks). There must be a singleton vertex presentation with no significant antenatal or intrapartum problems.
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/08/1998
Date of final enrolment	01/02/2002

Obstetrics and Gynaecology

Sunderland
SR4 7TP
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/09/2008		Yes	No